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CTRI Number  CTRI/2024/02/062464 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing different types of electric current stimulation applied on head in healthy people 
Scientific Title of Study   Comparison of polarity dependent cerebellar transcranial direct current stimulation on motor learning in healthy individuals  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srushti Sanjiv Desai 
Designation  Post-Graduate student pursuing Master of Physiotherapy, Neurosciences (Neurological Physiotherapy) 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9909021685  
Fax    
Email  srushti1.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthil D Kumaran 
Designation  Additional Professor, Dept of Physiotherapy, MCHP, MAHE, Manipal 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Senthil D Kumaran 
Designation  Additional Professor, Dept of Physiotherapy, MCHP, MAHE, Manipal 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE, Manipal 
 
Primary Sponsor  
Name  Srushti Sanjiv Desai 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Srushti Sanjiv Desai  Kasturba Hospital, Manipal  102, Neuro OPD, N1 Department of Physiotherapy, Baliga block, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9909021685

srushti1.mchpmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals between 18 – 60 years of age with no history of neurological diseases, no history of musculoskeletal disorders affecting the range of motion in upper extremity  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cerebellar transcranial direct current stimulation  The stimulation will be given for 30 minutes with a ramp up and ramp down time of 10 seconds each. The current intensity will be 2mA with a density of 0.8mA per square cm. Group 1 will receive unilateral cathodal stimulation, Group 2 will receive unilateral anodal stimulation, Group 3 will receive bilateral cathodal stimulation, Group 4 will receive bilateral anodal stimulation 
Comparator Agent  sham cerebellar transcranial direct current stimulation  10 seconds ramp up stimulation followed by stimulation being switched off for the following duration of 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy individuals between 18 – 60 years of age with no history of neurological diseases, no history of musculoskeletal disorders affecting the range of motion in upper extremity 
 
ExclusionCriteria 
Details  Individuals with MOCA score less than 26, visual or auditory problems, intracranial metal implantation, cardiac disorders, previous participation in any motor performance enhancement program, damaged skin on head and face 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reaction time through finger lift-off reaction time mobile application of Hackman group  Day 1 (pre) - baseline evaluation
Day 1 (post) - immediately after stimulation
Day 2
Day 8 / at 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Movement time & error through Moberg pick-up test
Movement trajectory through, ArmAbleâ„¢ virtual gaming device. 		 Day 1 (pre) - baseline evaluation
Day 1 (post) - immediately after stimulation
Day 2
Day 8 / at 1 week 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Following IEC approval and CTRI registration, volunteers will be screened and, based on inclusion criteria, participants will be included for the study. Participants willing to participate in the study will be asked to provide informed, written consent. On Day 1, participants will be familiarized with the procedure and baseline evaluations (t0) of the performance outcomes will be recorded. Following this, patients allocated the respective stimulation type group based on the randomization will receive the respective stimulation type. Immediately after the stimulation, re-assessment of the outcomes will be done (t1). Subsequently, outcomes will again be evaluated after 24 hours (t2) of stimulation and after 1 week of stimulation (t3). Data will be described via descriptive statistics and analysis will be carried out using SPSS version 16. 
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